Tandem Diabetes Care, Inc. ($TNDM)

[Audio gap] Tandem Diabetes -- Leigh Vosseller, Executive Vice President and CFO; and Susan Morrison, Executive Vice President and Chief Accounting Officer, right?

Administrative...

Administrative Officer. CAO, right? I think, Leigh, you wanted to start with some opening remarks.

Sure. Just a few comments on how we're kicking off the year, which is strong. We're celebrating a number of records that we've achieved, and this is in the midst of a number of transformational changes in the business as we are strengthening our business model. And so some of the records, I mean, many on the P&L this time. We had record shipments, record sales for our first quarter. We had record gross margin -- it's our highest first quarter gross margin ever. And it's really important to make that distinction because this is a quarter when we usually see seasonal pressure on margins, on cash flow. We also demonstrated free cash flow positive this quarter. So everything has started off really strong. We're excited to demonstrate some of the things that we're putting into effect as we talk about the coming quarters, but the launch of the PayGo model in pharmacy really just kicked off late in the first quarter. We started shipping direct in some of our markets outside the U.S. And so I would say we're firing on all cylinders, and we have a number of ways now that we can drive revenue different than before where we were heavily dependent on product innovation cycles, but we also have those as an opportunity this year as well. So it's really certainly an exciting time for us.

Right. Great. Maybe just kind of post Q1, you beat expectations on revenue. There was some shifting around some of the headwinds in Q1 to Q2. Maybe just kind of talk about some of the timing things and kind of what gives you confidence in the Q2 guide of $175 million in the U.S., and $80 million internationally.

Yes. So it really comes back to the 2 big business model transformations. And so we had to make a number of assumptions about how those would pace across the year in terms of execution. For PayGo, we really just got started in March, when it comes down to the implementation of that. So the way to think about it is at the beginning of the year, we were kicking off, focusing on amending and updating the contracts to adjust to this new model. And March is when we put the infrastructure into place to actually start taking orders. And so right on pace with where we expect it to be. For the year, we anticipate, because we're transitioning -- because we're giving up the revenue on the pump and putting it to the supplies, that it would create a revenue headwind. And so we had said it could be up to $5 million in the first quarter. We were just getting started. So it wasn't -- we weren't quite sure how it would spread across. But now we see that, that's going to push across, and we're expecting it to increase linearly across the year. The second piece of it is the timing of the headwind on our transition to going direct outside the U.S. And so that comes about because as we launch into new markets, we have distributors who are destocking their inventory in preparation. And at the very end of the last day, we buy back whatever is on their shelves. And so we saw about $1 million of headwind there where we had originally expected about $5 million. And so the timing of those were the influencing factor for the outperformance with strong fundamentals underneath that. And so we remain confident in the guide for the rest of the year. Second quarter, in particular, we were thinking about how those headwinds continue to play out. And so in the U.S., there's a number of factors underlying how that guidance was put together. It starts with delivery of pump shipments. And so we pointed people to that being what you want to watch this year because revenue might not track the same as it has in years past as we make these transitions. So we expect that we will see a similar seasonal curve to what we did in years past. From Q1 to Q2, that means pump shipments step up about 20%. So we factored that in, again, with an increasing scale of the headwinds for the transition to PayGo. And that's been a common question of how do I think about that spreading. It really just will continue to escalate across the months of the year. And as expected, I mean, we saw April step up from March. And so it's moving down the path that we expect to see to drive towards those assumptions we set for the full year. Outside the U.S., there are so many things to talk about, Travis, so many puts and takes. Outside the U.S., in the transition to going direct, we expect some of the headwind to shift into the second quarter. So $3 million to $4 million because of the inventory buyback situation. But also, we're launching Mobi outside the U.S. for the first time. It will start scaling in a few markets in the second quarter, but some not until the third quarter. So we think the distributors will push the timing of their orders into the third quarter preparing for that Mobi launch. So those are the things that we took into consideration when we set up the expectations for Q2 and we feel very good about where we're headed.

Great. Maybe just digging in a little more on the pharmacy side. Maybe the first question, the Q1 '26 pharmacy percentages versus Q4, why is that not comparable?

Yes, it's a great question. When you think about pharmacy for Tandem, last year, it was a whole different design. So last year, it was structured much more like the DME contracts, where there was reimbursement for the pump. And in fact, it was only for Mobi in the pharmacy channel to start with. And so we were getting a premium for a pharmacy pump versus a DME pump, and then we had revenue for the ongoing supplies piece. When we came into this year, it's almost, you could say, a race and reset. So it was a start over at the beginning of the year, resetting all the contracts to this pay-as-you-go model. So Q4 still had pump revenue in it in the pharmacy. When you look at Q4 to Q1, there was a slight step down in the revenue dollars related to pharmacy. And the majority of that really did come from the pump dollars zeroing out when it came to that aspect. There was a little bit on the supply side. I would put those factors probably in the noise level category, a number of contributions to it. You have your traditional -- you have some seasonal timing when people order in the fourth quarter sometimes at higher levels and don't reorder right away in the first quarter, maybe not until the second quarter. We did have a little bit of impact from an infusion set shortage from one of our key suppliers, which impacted pharmacy and DME alike. And then just the normal noise around distributors, sometimes the stocking patterns. But really, the biggest difference I would point to the pump difference.

How do we think about the pharmacy mix Q2, Q3, Q4?

Sure. So in the first quarter, keeping in mind, we really didn't set up the infrastructure and kick it off until the last few weeks of the quarter. So really didn't expect much to happen at this time. We gave a few metrics for to think about really 2 different work streams for pharmacy or 2 ways we're measuring success there. One is how many people buy a pump under the PayGo model. So essentially giving them a pump for free. And that ended up being about less than 5% of our shipments in the quarter, which was very much in line with our range of assumptions. The other element is how many people in our installed base. So we have 320-ish thousand people in the U.S. today. How many of those people in their recurring supply order that we could convert over into the pharmacy. And that happened to be about less than 5% as well. So both of those, it's a different way to think about it for the year, what the average will be. But we expect from Q1, it will continue to step up each quarter across the year, growing in a percentage towards the overall average goal for the year.

Maybe just talk a little bit more about what happened in March with the launch of PayGo?

Sure. So it's very interesting. I think there is the assumption that it's on, you just go and you go crazy. What we really do, I said at the beginning, we were focusing on getting the contracts in place really in those first few months. So we had to get them transitioned over. So every contract we had had to be amended. And for those first few months, we weren't even pushing pharmacy with patients or physicians. We just needed to get everything right set. Then we kicked off and we implemented the infrastructure. And you can think about it is this is not insurmountable. It's just the nature of the launch. There was an end-to-end change in the processing, so how we engage with the patients, how a physician writes and sends a script into Tandem, how our employees move the script from one end of the funnel to the other, ultimately to fulfillment. And so a lot of people had to change what they do on a day-to-day basis. A lot of physicians have to change their approach. And so you can think about our employees, we can train them and have them ready to go live. With physicians, we have to reach thousands of people and train them on the new approach. It's not hard. It's just a matter of getting to them all, making sure they understand it. And that's really the big effort that was going on and still going on today. But that's where the focus was when we turned it on in March, is getting everyone lined up to understand the new flow of things. And so it's just the nature of being early in the cycle.

Are all the contracts amended at this point?

So we -- there are still some. So we've got the major PBM contracts amended, and now we're really focused on the formulary additions. And we've been very successful there. And this is probably the most important metric from the first quarter is, I guess, what opportunity did we build for ourselves. So how many people actually have access through the pharmacy channel. And so basically, you think about starting over at 0, you get your PBM contracts amended and you have some automatic formularies that you have. But then we've also added formularies by going out and talking to different payers and employer groups and getting them signed up for it. And so we've grown now to approximately 40% coverage on formularies. If you think about what does that mean, where are we versus where we expected to be, our goal for the year was to be somewhere 40% to 50% coverage. And so the fact that we're already at the low end of that range is very meaningful. And also important to note, we're doing this off cycle. So there are traditional cycles when you go out and you get additions to formulary coverage. It's typically a January 1 or July 1 time frame depending on which payer you're talking to, which PBM cycle it is. And we're doing this as we go along the way. And so we've made great strides towards building what I would call that opportunity for ourselves, which puts us in the right place we need to be to achieve the pharmacy metrics that we've laid out in the assumptions for our guidance this year.

Can you talk a little bit more about -- because there's turning on the PBM contracts, but there's also talking to the payers and getting those on formulary. Like how are those conversations going with payers to say, oh, I'll cover this in pharmacy.

Yes, going very well. So it's improved a lot, I would say, even since a year ago when we first started going into the channel, there was still a lot of question about how to handle a product that was formerly DME as a shift over to the pharmacy channel. And there was no preset way or established reimbursement model. And so we learned a lot across the year in our conversations. And we built up a fair amount of formulary coverage last year, but we realized to get to the optimal long-term coverage for the business, we needed to think about a shift in the model. So as we gathered those learnings, it was late in 2025 where we decided to add t:slim supplies to the pharmacy channel contracts. And then as we shifted into this year, we said, what we really need to make this transition. And it's important -- we're not going to be able to dabble in it or go slowly or do a little bit here, a little bit there. We needed to go full bore. And so that's where we got to for 2026 is to really drive this hard and as fast as we can.

When you think about the incentive for an existing patient, the payer is paid for in the DME channel last year, the incentive to allow them to come to the pharmacy channel. How is that going in those conversations?

Yes. So it's an interesting topic. When we go to the pharmacy side, they're not talking about where did they acquire their pump versus where they are today. It's -- payers are accustomed to patients and moving between different plans. It happens naturally when employers change plans. So there's a lot of shifting all the time, which is why I would say many times when you talk to payers about the economics, they take a very short-term view on it, and they look usually more at 2- and 3-year reimbursement cycles, not long-term value necessarily. So when they're comparing a few years in pharmacy to a few years in DME with an upfront payment, it's not too dissimilar. So there's not a lot of question or conversation around that. It's really on the pharmacy side, they're very focused on volume. We've done a great job, our team, I should say, of helping the payers and the PBMs understand the value of what we offer, the true clinical value that comes with being on our product. So the fact that people have better outcomes, which means their A1c improves, which means they have better sleep, which means they have better health overall, which means it might reduce the drugs that they have to take, it can reduce the hospitalizations that they experience. And so they see that financial benefit lined up against what we can offer. And with our large installed base of customers and the value they place on volume, they're willing and ready for us to drive to that channel.

Do you find in the pharmacy channel, like selling on your clinical data matters more than in the DME channel?

I think it does. I think it was starting to resonate with the DME channel, but certainly more so in pharmacy. And back to that idea that they can view a patient across the spectrum in terms of what they pay for them. In the DME channel, there's not that same capability, if you want to call it that, because the types of products in DME don't usually drive that kind of value to the overall health of a patient, not like in the pharmacy, which was designed for drugs, which have many other benefits. And so it's just a different animal.

We hear a lot that payers are willing to pay more in the pharmacy because they have more visibility on their patients. Like is that -- like what does that mean?

Yes, that's certainly what we're seeing. So I mean, this -- the pricing bar was set in the market when we came into it. And so we're excited to go in and take the same advantage of it as everyone else. For us, it's helpful to us from an economic perspective, for sure. But the other piece of it is, it's really the value it provides to the patients and the doctors. And so the value pharmacy provides to a patient, which is they can go from DME, where they pay $1,000 to get on a pump, and that's at the optimal point. That's -- if they've met their deductible, that's how they move forward. In pharmacy, they might have an out-of-pocket, but we have the ability to help assist them with that. And so we can get the co-pay down. And so since we're doing the PayGo model now, it went from whatever their out-of-pocket was to 0. So now all they have to think about as an individual is being able to pay for their supplies over time, and that's where we can make the biggest difference for them.

On the PBM incentives, obviously, rebates matter. How are you thinking about volume and dollars rebates? I think your competitors, one of the things they talk about is like the amount of dollars and rebates they pay -- not necessarily on a percentage basis -- is a lot bigger than anybody else's. And so that matters to the PBM.

Yes. So it kind of doesn't matter how you think about it. For us, it's a volume play. And so regardless of the percentages, they can get more rebates from us just because we have so many customers we can offer to them. And so that resonates very well.

Taking an existing patient from the DME to the pharmacy, what all is involved in that process?

Yes. When -- so it starts with the patient typically orders once a quarter. And so when they go to place their first -- their supply order, what we do is we take the information and we will check their benefits in both channels. If we have formulary coverage for that patient, we will offer back to them: here's an opportunity for you, here's the out-of-pocket. Again, we can influence how much that is versus what their DME benefit might be. So we get them to understand it. And when they say, yes, I want to move forward, then we have to talk to the physician because it does require a new prescription. So anyone that switches, and that's where sometimes it can take time. That's why it's not immediate and simple to go, great, I'll just switch you over. There's a little work involved in doing that. And that's not something that we naturally have to do today for supply orders. So it creates more effort, which means our teams that are usually focused on pumps now have to be focused a little bit more and differently on getting supply orders. Our distributors have to do the same. And it may mean that our physicians have to take a pause from their routine activities and also then write this new prescription when they ordinarily would not. So nothing insurmountable. But I think what it helps people appreciate is it does take some effort to get people shifted over.

So you know what a patient's co-pay is in the DME, as you have that visibility?

Absolutely.

So you can incentivize that patient through a lower co-pay to make that transition over patient by patient.

Yes.

What's the -- how involved and how can you help the bottleneck being get the patient back to the doctor to get a script, like how involved in that process can you be and kind of move that along?

Very. So our teams, that's what their job is, is that they need to call the physician. They need to get them to write the script that's needed and get it into the system so we can get it processed. And there's also a time element. So if a physician doesn't get there, I'm going to say, in time to get it back to us, patients need their supplies. So we might have to move forward with the DME order this time, but put them in the queue for next time thinking about what that next script might look like.

It's probably early, but any sense for, I guess, patients saying yes to go to the pharmacy channel versus no? And why would they say no?

Yes. Interesting dynamic. Some people, I think just naturally, there's a skepticism like, I don't know what you mean by this, why would it be cheaper, what's the difference here. Some people are like -- oh, I'm comfortable, I like where I get my supplies today; I don't need to make any changes. So there's an education that needs to come with this for us to help people understand. And it's new. And so we look forward to continuing to help educate people, physicians and patients alike, and they might be more inclined to get their physicians' advice before they make any changes like that. But it's just human nature, I would say.

Any sense for like is -- are patients incentivized on deductibles in the pharmacy versus DME, given all those things that they're buying?

Yes. So there are -- we have always experienced the deductible challenge, I would say, in the DME channel, which is why you see such a seasonal curve to our business. Pharmacy also has deductibles in many cases. What we saw was the deductible impact has been more pronounced in DME as more of the diabetes companies have moved into pharmacy, and so they're not using up their DME benefits as fast. And so it will help with us being in the same channel as the CGMs, for example, because that will help people meet their deductibles more quickly if they have them. And so that's something that we're still gaining that experience. We definitely know the seasonality in DME. In pharmacy, it appears there may be some there as well, and that's what we're going to be learning as we go.

You're doing co-pay buydowns, right, on all these patients?

Yes.

Does the tier matter in the pharmacy that you're on then at that point?

It does. And so that's part of the gross to net. And so where you land on the tiers influences the patients' out of pocket. And that's where the learnings as we've negotiated this year, our structure and understanding what the net will ultimately shake out to be is understanding our levers for when we negotiate in the future. So is it -- very simply, is it worth it to pay a higher rebate in order to pay less co-pay assistance if you're on a higher tier? So we are looking at all that and taking that calculus into consideration.

So is the math basically, if you go Tier 2, you pay a higher rebate, but you have to buy down the co-pay versus you go Tier 3, is it kind of co-pay buy down versus rebate? Is that the math you're doing?

Yes, yes, it is. And it does -- it varies by payer and PBM too. So there's a lot of factors to consider.

But the idea is that basically to the patient, there's kind of very little out-of-pocket cost or it's incentivizing them.

Yes, yes.

Any other reason why it matters to be on like Tier 2 versus Tier 3 from your perspective?

I would say that's the primary. We also will learn things this year. I mean, our volumes are very low right now. So we're getting -- the information we're gathering today falls more into the anecdote category as opposed to real trends. And so as we continue to drive the penetration and execute on this, we'll gather more information that can inform us as we think about future conversations.

Great. New starts, though, a common question I got was they were down low single digits in Q1 year-over-year, but you're still guiding to -- I think, 10% to 11% for the year.

So the guidance for the year for pump shipments in total is 10% to 11% growth. That's a combination of renewals and new starts. So maybe a few points here to highlight. Renewals, I think a lot of people have said -- oh, you won't see growth this year, Tandem, because your opportunities didn't grow this year. We still have a fair amount of people from older cohorts that give us the opportunity to drive growth in renewals. From a new start perspective, just back to 2025, we were seeing some pressure, particularly in the last 12 to 24 months as we were seeing a declining opportunity from some competitive conversions. And we probably hit the low point, if you want to call it that, middle of '25. So since then, we've been recovering and new starts are improving, and we expect them to return to growth in the second quarter. So where we landed in the first quarter was very much in line with where our expectations were in terms of trending out of it. It's the pharmacy opportunity and the new products that we're launching that are really going to help drive that new start strength and the fact that we won't have that headwind from the decline in the competitive conversions that we were seeing.

New starts growing again in Q2 in the U.S., right?

Yes.

Like low single-digit growth or...?

We haven't given a specific figure, but that it will return to growth.

How do we think about it kind of in the back half of the year kind of beyond Q2?

Yes. So what we'll start to see is renewals still have really strong growth in the early half of the year, new starts returning to growth, and it will start to turn around as we go out the back half and into next year. You'll start to see new starts being the key driver. And we do have high confidence that we can return to that. When you think about pharmacy, it removes one of the #1 barriers. There's 60% of people not using pumps today, and a big piece of that is cost. So especially people who've wanted a tubed pump with that DME headwind that you have for a patient from the out-of-pocket cost, taking that away can make a big difference in people's ability to move forward with pump therapy. That's one lever. We also have the other levers with all of our new product introductions that are underway that can also help drive that strength. And so we feel very confident that we will be able to turn that around for MDI conversions and really start to drive the growth in the future.

Do you kind of get back to high single-digit new start growth longer term like in '27?

We expect -- so our long-term goal is, just generally speaking, double-digit growth for the business. And so we do need to return to a real strength in driving more people to Tandem for pump there.

It sounds like you're betting really on just the market accelerating, right?

I think the market accelerating with us being a big contributor to that.

Okay. From pharmacy and new...

Pharmacy and new products. Keep in mind, we -- you'll get to products, I think, eventually. But we are going to be -- we have new products today between new CGM integrations. We have new indications. But one that we're going to be doing now is the market has somewhat been divided between tubed and tubeless category. We're stepping into the tubeless category this year, which is going to be a significant difference in terms of the opportunity base.

Do you think Tobi is competitive enough in the tubeless market?

Yes, it's our entry into that segment of the market.

Yes. How do you think it stacks up though, compared to some of the other patch pumps that are coming on the market?

Sure. The feature I'd highlight is that you're able to wear it for 7 days. And so the fact that you're able to change your insulin within that 7 days, but the plate stays on your body, that's a huge advantage for people. And so when we see that, and then it's also a durable pump, so you're able to recharge it during that period. You're not throwing away coin cell batteries and electronic board every 3 days and that ability again to change that insulin separate from the infusion site, I think those are some really standout features in addition to being able to deliver bolus insulin directly from the pump. You don't need to have the controller in order to be able to do that.

Then how -- when, let's say, Tobi is successful, like where do we see it in your metrics? Is it new starts accelerating? Is it mix the pharmacy moving forward at a faster rate? Like how do we see it in your numbers?

I think new start is going to be the primary contributor because we are able to enter this new segment. I think it will benefit across all of those metrics, but new starts is where I'd focus.

Have you filed it yet at this point, Tobi?

We will announce it on earnings calls. We're very sensitive letting the consumer market know about these because it's not yet available. So our marketing teams, our sales teams, they can't answer any product questions or anything yet. And so what we said is we'll file it in the second quarter. We're confident in that timing, and then we're planning for launch before the end of the year.

Is there a sense that we have seen shipments slow down ahead of product launches in the past?

That's what's so cool about this product is it's interchangeable. The pump is exactly the same. So if you bought a Mobi pump a year ago or a year from now, you're able to use it either with a tube or a tubeless cartridge. And so because of that, it allows as soon as we get clearance, we can really market that and making sure that people are aware it's the exact same pump. And then when they do their regular supply orders, it's just how do you want to wear your device.

Okay. And then margins this quarter already really strong before the pharmacy comes through. So I don't know if there's anything you'd call out on Q1 margins. To me, it was a surprise.

A very nice surprise, wasn't it?

Yes.

So we grew our margins 5 percentage points year-over-year. That's the biggest step-up we've had in margin, our highest Q1 margin in our history. Another notable point is that it was higher than our overall average for 2025. That's the first time I think our first quarter has exceeded the prior year because we usually see that seasonal step down. And it comes from the power of pricing. So when you think about even that small percentage through pharmacy was 6% of sales in the first quarter, it made that much of a difference in terms of margin improvement. We also still have margin or price improvement in the DME channel, and we're starting to see the benefit of being direct outside the U.S. So all of those pieces together were a strong contributor. But that's not to say we're not doing things on the product side. We also had improvement in our product costs as Mobi continues to grow and scale. We're leveraging that overhead from it being a new product at smaller volumes. We're gaining experience with it. And so that will also continue to be a contributor going forward.

When -- before we were talking about like the pharmacy percentages, Q2 stepping up Q3 kind of sequentially over the year, will that show up in margins immediately?

So what we've guided to for now is Q2 margins roughly in line with the first quarter. The step-up in revenue from Q1 to Q2 is more on the supply sales. And globally, when you think about it, pumps still have the highest gross margin versus supplies. But that will be a contributor in Q3 and Q4 as we scale upwards to our 60% goal for the fourth quarter of this year. So you'll continue to see good progress.

Some conservatism built into Q2, though?

So it's -- I would say that we're always thoughtful about all of the moving parts, a lot of puts and takes. We have much more visibility into the next quarter than we do for the remainder of the year. So we think about those movements when we built that assumption.

How do you think about like kind of profitability, maybe '27? Is '27 a year where like the business starts to really turn on the profitability side?

Yes. I would argue that it's turning quite a bit this year, I guess, compared to what we've seen in years past. But yes, -- it's -- people often tell me it's hard to model pharmacy without seeing a big upside there. And so we're very focused on head down execution this year so we can really drive that. But that pricing difference can make a huge difference from profitability. But I'll say we're not solely relying on price. I mentioned product cost improvements is important. We're also very focused on disciplined spending from the operating expense side, ensuring that we're making the right investments, looking for ways to fund those investments with efficiencies in the organization because there comes a day -- you don't want to just rely solely on one factor. So we need to make sure that we have the good cost structure in place to go with the pricing benefit.

How are you thinking about market share in the pump market? And other companies are launching new products too, you're launching new products. So from a competitive standpoint, do you think you're taking share and from who?

I think we are growing the market. We are bringing more people on to pump therapy. There's always going to be some level of share exchange. And we have seen increasingly as we enter or become more competitive with patch pumps, where that's an area that we are able to pull from. But in general, our focus is bringing people from multiple daily injection on to pump therapy. 60% of the market presents a huge opportunity.

Very fair answer. Anything that I haven't covered that you wanted to touch on?

Yes. I think another thing I'll highlight is the good retention of our customers. And so there's a lot of transition going on, and we're not just focused on the next new customer. We're really focused on the customers that we have today, improving that customer experience, making sure it's the best ever. And we monitor our retention trends very closely through our renewal behaviors, but also just supply ordering patterns and what we see is continued strong retention up through the first quarter. And so I think that's very important for people to understand. There's sometimes -- there's a question of if you go into pharmacy, will people stay with you? We've demonstrated in many ways multiple times even when patients are offered the choice. In warranty, they could switch to pharmacy for the past few years. Out of warranty, they could switch to other products, they stick with us. And so we feel really good about this transition that we're making, keeping the customers we have happy and with us and attracting the next level of new customers.

Great. Anything left for you, Susan?

I just wanted to say thanks so much for having us again, and it's a really exciting time for our company across the business and globally.

All right. Great. Thanks for coming.

Thank you.

Thanks for having us.